Food As Medicine to Reduce CKD Burden in Health Disparity Populations

NCT07759401 | Not Yet Recruiting

• 2 other identifiers: STU202600551R01DK143078-01A1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

Healthy eating plays an important role in kidney and heart health, and programs that use food as medicine can help improve diet and overall health, but the best ways to support healthy eating in community settings are not well understood. The purpose of this study is to compare two study groups to see which is more effective at improving kidney health and related health outcomes in adults with chronic kidney disease. One group receives fruits and vegetables with cooking education, and the other receives fruits and vegetables alone. The results may help researchers develop community-based programs to improve kidney and heart health, especially in populations at higher risk for kidney disease. If the participant joins the study, the participant will complete a baseline visit, a 6-month visit, and a 12-month visit. Visits include questionnaires about the participant's health, diet, and cooking habits; a urine sample; a blood sample; blood pressure, height, weight, and waist measurements; and a brief, painless Veggie Meter® scan to measure fruit and vegetable intake. Participants will pick up weekly fruits and vegetables for 12 months. Those in the cooking group will also attend 12 weekly cooking and nutrition classes and receive follow-up newsletters and optional monthly virtual sessions. Depending on the group to which the participants are assigned, the total time commitment for the participants in this study will range from approximately 3 to 15 hours. Participation is voluntary, involves minimal risk, and all information will be kept private. Possible risks include brief pain or bruising from the blood draw, mild discomfort from urine collection, minor risk of cuts or burns during cooking, and some questions may feel personal; the participant may skip any question. There may be no direct benefit to the participant, but the participant's participation may help improve nutrition and kidney health programs in the community.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; CKD; Food is Medicine

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Urine Albumin to Creatinine Ratio at 6 months

  Diagnostic laboratory results for urinalysis will determine whether urine albumin-to-creatinine ratio (UACR) is reduced to a greater extent with the FV + Cook intervention as compared to FV Only at 6- months. High levels of urine albumin excretion predict increased risk for subsequent eGFR decline and its change during follow up is directly associated with risk for End-Stage Kidney Disease (ESKD).

  Baseline (enrollment), 6 months

• Change in Urine Albumin to Creatinine Ratio at 12 months

  Diagnostic laboratory results for urinalysis will determine whether urine albumin-to-creatinine ratio (UACR) is reduced to a greater extent with the FV + Cook intervention as compared to FV Only at 12-months. High levels of urine albumin excretion predict increased risk for subsequent eGFR decline and its change during follow up is directly associated with risk for ESKD.

  Baseline (enrollment), 12 months

Secondary Outcomes (12)

• Change from Baseline in Systolic and Diastolic Blood Pressure at 6 months

  Baseline (enrollment), 6 months

• Change from Baseline in Systolic and Diastolic Blood Pressure at 12 Months

  Baseline (enrollment), 12 months

• Change from Baseline in Glycated Hemoglobin (HbA1c) at 6 months

  Baseline (enrollment), 6 Months

• Change from Baseline in Glycated Hemoglobin (HbA1c) at 12 Months

  Baseline (enrollment), 12 months

• Change from Baseline in Body Mass Index (BMI) at 6 Months

  Baseline (enrollment), 6 Months

Other Outcomes (16)

• Change in Dietary Intake [total energy intake (kcal/day)]

  Baseline (enrollment), 6 months

• Change in Dietary Intake [total energy intake (kcal/day)]

  Baseline (enrollment), 12 months

• Change in Dietary Intake [total fat intake (g/day)]

  Baseline (enrollment), 6 months

Study Arms (2)

Fruits and Vegetables (FV) Only (Control)

NO INTERVENTION

This group will receive a prescribed amount of free (at no charge) base-producing FV for 12 months through pick-up at one of two Brother Bills Helping Hand (BBHH) sites. BBHH clients pick up groceries weekly from either their main West Dallas campus or the South Dallas Community Market. This calculated FV amount averages 2-3 cups of base-producing FV daily. The FV Only group is considered standard care.

Fruits and Vegetables + Nutrition and Cooking education

EXPERIMENTAL

Participants will receive the same free base-producing as the FV Only group plus 12 weekly group nutrition and cooking education classes delivered through the UTSW Culinary Medicine program. Classes include hands-on cooking instruction, nutrition education, goal setting, behavioral strategies, and skill-building activities designed to improve healthy eating behaviors, self-efficacy, and motivation.

Behavioral: Culinary Medicine Nutrition and Cooking Education

Interventions

Culinary Medicine Nutrition and Cooking Education BEHAVIORAL

A 12-week group-based culinary medicine program integrating nutrition education, cooking instruction, and behavior change strategies to support healthy eating and meal preparation.

Fruits and Vegetables + Nutrition and Cooking education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women of age ≥ 18 years and able to give consent;
• willingness to participate in a 12-month study;
• elevated albumin to creatinine ratio (ACR) (≥ 30 mg/g) determined by point-of-care urine dipstick during health screen;
• Reside in a low-income area or visit a food pantry due to food insecurity

You may not qualify if:

• whose urine dipstick does not indicate micro- or macro-albuminuria (ACR \<30 mg/g),
• currently receiving dialysis or need dialysis,
• have received or need a kidney transplant,
• pregnant or plan to become pregnant in the next 12 months,
• baseline urine potassium \> 60 mEq/g creatinine (baseline excretion below this level was not associated with hyperkalemia when fruit/vegetable were paired with kidney-protective drugs,
• urine ACR values indicate nephrotic proteinuria, and
• CKD stage 5 demonstrated by elevated estimated glomerular filtration rate (eGFR) obtained during baseline measures.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Brother Bill's Helping Hand

Dallas, Texas, 75212, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Messiah, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Heather Kitzman, PhD

  Parkland Health

  PRINCIPAL INVESTIGATOR

• Donald Wesson, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Ruiz, BS

CONTACT

469-285-6848; emilie.ruiz@utsouthwestern.edu

Meera J. Patel, PhD

CONTACT

469-852-8557; Meera.Patel@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2032
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)